SUPPLY CHAIN ARTICLES

• Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

  Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

• "Mirror, Mirror…": Reflections On Reducing mRNA Production COGS

  Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.  

• “Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA

  It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).

• The RNA Therapeutics Supply Chain: A Platform of Relationships

  Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

• Beyond The Gold Standard(s): Modernizing Oligonucleotide Synthesis

  A few weeks ago, I had the chance to sit down with OPT Congress speaker Phil Baran, Richard Lerner Chair Professor, Department of Chemistry, Scripps Research. Baran was slated to (and did) present a keynote on the innovations shaping the next generation of oligo synthesis. Here, I share the biggest takeaways I had from our conversation, touching on how he sees the science of oligo chemistry and manufacturing advancing in the near and far future. 

• Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

  One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.